Clinical trial · Interventional
A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
A Randomized, Open-Label, Multi-Center, Phase 2 Clinical Study of Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Camrelizumab、Rivoceranib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- Camrelizumab Plus Rivoceranib (Apatinib)
- interventionNames
- Drug: Camrelizumab、Rivoceranib
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Camrelizumab
- interventionNames
- Drug: Camrelizumab
Primary outcomes (1)
- measure
- Recurrence-Free Survival (RFS), as Determined by the investigator
- timeFrame
- Randomization up to approximately 43 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects with a histopathological diagnosis of HCC. 2. Subjects who have undergone a curative resection or ablation (radiofrequency ablation \[RFA\] or microwave ablation \[MVA\] only). 3. No previous systematic treatment and locoregional therapy for HCC prior to randomization. 4. Absence of major macrovascular invasion. 5. No extrahepatic spread. 6. Full recovery from Curative resection or ablation within 4 weeks prior to randomization. 7. High risk for HCC recurrence after resection or ablation. 8. For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization. 9. Child-Pugh Class: Grade A. 10. ECOG-PS score: 0 or 1. 11. Subjects with HCV- RNA (+) must receive antiviral therapy. 12. Adequate organ function. Exclusion Criteria: 1. Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar HCC; other active malignant tumor except HCC within 5 years or simultaneously. 2. Evidence of residual lesion, recurrence, and metastasis at randomization. 3. Moderate-to-severe ascites with clinical symptoms. 4. History of hepatic encephalopathy. 5. History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage. 6. Active or history of autoimmune disease. 7. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity. 8. Cardiac clinical symptom or cardiovascular disease that is not well controlled. 9. Severe infection within 4 weeks prior to the start of study treatment. 10. Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy. 11. Thrombosis or thromboembolic event within 6 months prior to the start of study treatment. 12. Known genetic or acquired hemorrhage or thrombotic tendency. 13. Previous or current presence of metastasis to central nervous system.
References
Publications (0)
Data not yet available